Carilex VT¿200-i NX

510(k) Number

K231646 ↗

FDA Product Code

OMP

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Carilex

  Class IIa

  CE/MDR

• VT·One, VT·One 60days

  Class II

  FDA 510(k) K161410 Active Cleared 13 Oct 2016

• Carilex

  Class IIa

  CE/MDR

• Carilex

  Class IIa

  CE/MDR

• Carilex

  Class IIa

  CE/MDR

• Carilex

  Class IIa

  CE/MDR

See all devices from Carilex Medical, Inc. →

• What clinical settings is the Carilex VT200-i NX intended for use in, and how does it support wound management?

  The Carilex VT200-i NX is designed for use in general and plastic surgery settings, including hospitals, surgical centers, and outpatient clinics. It supports wound management by applying controlled negative pressure therapy to promote healing in chronic or acute wounds. The device reduces edema, enhances granulation tissue formation, and improves perfusion, which helps accelerate recovery and optimize outcomes for patients with complex wounds.

• Is the Carilex VT200-i NX a single-use or reusable device, and what does this mean for clinical workflows?

  The Carilex VT200-i NX is supplied as a reusable, non-sterile unit, meaning it is intended for repeated use in clinical environments after proper cleaning, disinfection, and maintenance. This design allows for cost-effective integration into workflows where multiple patients may require negative pressure wound therapy over time, though clinicians must follow manufacturer guidelines to ensure proper sterilization and hygiene between uses.

• What regulatory pathways has the Carilex VT200-i NX followed, and what does this indicate about its compliance?

  The device has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming compliance with U.S. and EU regulatory standards for negative pressure wound therapy systems. The 510(k) clearance demonstrates that the Carilex VT200-i NX is deemed substantially equivalent to a legally marketed predicate device, while MDR authorization ensures adherence to stringent EU requirements for safety, performance, and clinical efficacy.

• Does the Carilex VT200-i NX come with adjustable suction levels, and how might this feature benefit wound care?

  Yes, the Carilex VT200-i NX includes adjustable suction levels, allowing clinicians to tailor therapy to specific wound conditions. This flexibility enables precise control over negative pressure, which can enhance healing by promoting blood flow, reducing bacterial presence, and supporting the formation of new tissue—critical for managing wounds of varying severity and responsiveness.

• What storage and handling precautions should be taken with the Carilex VT200-i NX to maintain its functionality?

  While the device itself is non-sterile, proper storage and handling are essential to preserve its functionality and hygiene. Clinicians should follow the manufacturer’s guidelines, which likely include storing the unit in a clean, dry environment away from direct sunlight or extreme temperatures. For reusable units, adherence to cleaning, disinfection, and maintenance protocols is critical to prevent contamination and ensure reliable performance across multiple uses.